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December 8, 2010

Kyowa Hakko Kirin Announces Results from US Phase 1/2 Clinical Trial of
KW-0761 (Anti-CCR4 Humanized Monoclonal Antibody) in Patients with
Cutaneous T-cell lymphoma

Kyowa Hakko Kirin Co., Ltd. (Tokyo Japan; President and CEO: Yuzuru Matsuda; hereinafter referred to as “Kyowa Hakko Kirin”) announced that results from a Phase 1/2 clinical trial of its KW-0761 conducted in the U.S. were presented at the 52nd American Society of Hematology (ASH) Annual Meeting held from December 4 to 7, 2010 in Orlando, Florida, United States.

KW-0761 is an anti-CCR4 humanized monoclonal antibody created using POTELLIGENT®, a technology developed exclusively by Kyowa Hakko Kirin to produce enhanced antibody activity. KW-0761 recognizes CCR4 as an antigen and depletes target cells through Antibody-Dependent Cellular Cytotoxicity (ADCC) activity.

The presentation (abstract number: 962) pertained to a multicenter Phase 1/2 clinical trial in patients with cutaneous T-cell lymphoma that had previously been treated. There trials were sponsored by Kyowa Hakko Kirin Pharma, Inc. In this clinical trial, 42 subjects were administered KW-0761. In the Phase 1 dose-finding portion, Dose Limiting Toxicity (DLT) was not observed. The most common adverse events were nausea, headache, chills, fever, drug eruption, diarrhea, back pain, vomiting, and so on. Most of adverse events were mild to moderate in severity.

Efficacy was evaluated in 38 subjects. which included 16 subjects with Sezary syndrome (SS) and 22 subjects with mycosis fungoides (MF). The overall response rate was 42% (SS: 50%, MF: 36%),including 3 complete responses. These data demonstrate that KW-0761 may be an effective treatment for subjects with previously treated cutaneous T-cell lymphoma.

Kyowa Hakko Kirin places its focus on the field of cancer with antibody engineering technologies at its core. The company aims to continuously create revolutionary new medicines to contribute to improving cancer treatment and QOL of cancer patients.



The following shows the overview of US Phase 1/2 clinical trial presented at the ASH

1. Summary of the study

Study objective To evaluate the safety and efficacy of KW-0761 administered intravenously in patients with peripheral T-cell lymphoma and cutaneous T-cell lymphoma that has been previously treated.
Study design KW-0761 was administered at 0.1 mg/kg, 0.3 mg/kg or 1 mg/kg once a week for four times, followed by a 2-week observation period. For cases exhibiting efficacy or good stability, the administration had been continued for every two weeks.
Target patient
enrollment
47 patients
Primary endpoint Safety and Efficacy (overall response rate, etc.)

2. Outlines of the main data presented at the ASH

Dose finding No DLTs were observed up to 1 mg/kg. Thus, the maximum dose
(1 mg/kg) was selected for Phase 2 trial.
Safety The safety was assessed in 42 subjects.
Adverse events: nausea, headache, chills, fever, drug eruption, diarrhea, back pain, vomiting, and so on.
Severity: Most of adverse events were mild to moderate.
Efficacy The efficacy was assessed in 38 subjects with T-cell lymphoma.
Diseases: 16 subjects with Sezary syndrome (SS) and 22 subjects with mycosis fungoides(MF)
Overall response rate: 42% (SS: 50%, MF: 36%) Breakdown: 3 subjects in complete response and 13 subjects in partial response


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